MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE; FCG KIT, NEEDLE, BIOPSY

Model Number	G31518
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) are all related, unused lots of echo-1-22 are also being returned.Two events occurred however it is unknown with which lot, therefore each complaint will be assessed as the event description until clarification is received on which lot the malfunction occurred on.Each lot is "suspected" and fda mdr guidance states each suspected lot shall be reported individually.Additional information received indicates that they are unsure if the needle was fully retracted prior to patient removal, therefore a conservative approach is going to be taken until further clarification is received.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
As reported to customer relations: "needles and sticking during ultrasound procedures, when trying to actuate the needle through the endoscope and out of the catheter.Procedures completed by using another device (may have been cook, different gpn, may have been competitor device)." additional information provided by (b)(6) on (b)(6) 2018: "i was not in the cases and customer reported to me information i in turn reported to you.Customer does not have further detail.I wish i could be of more help." additional information received: "was the needle fully retracted when the device was removed from the patient? unknown.".
Event or Problem Description
(b)(4) are all related, unused lots of echo-1-22 are being returned.Two events occurred however it is unknown with which lot, therefore each complaint will be assessed as the event description until clarification is received on which lot the malfunction occurred on.Fda mdr guidance states all suspected lots are to be reported individually.In the patient notes it indicates that they are unsure if the needle was fully retracted prior to patient removal, therefore a conservative approach is going to be taken until further clarification is received.As reported to customer relations: "needles and sticking during ultrasound procedures, when trying to actuate the needle through the endoscope and out of the catheter.Procedures completed by using another device (may have been cook, different gpn, may have been competitor device)." additional information provided by dm on (b)(6) 2018: "i was not in the cases and customer reported to me information i in turn reported to you.Customer does not have further detail.I wish i could be of more help.".
Additional Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining (b)(4).Importer site establishment registration number: (b)(4).As it is unclear as to which lot number the issue was found (used) four pr¿s have been opened for the needle sticking issue-(b)(4).An additional pr has been opened for unopened/unused devices returned this pr will deals with lot number c1413422 and the reported issue of needles sticking/binding.Device evaluation the echo-1-22 device of lot number c1413422 involved in this complaint was not returned for evaluation.With the information provided document based investigation was conducted.Possible root cause : a definitive root cause for the customer complaint could not be determined, however a possible root cause for this issue may have been that the endoscope was in the flexed/twisted position, as indicated unknown is additional information received causing difficulties when trying to actuate the needle through the endoscope.The customer complaint is confirmed based on the customer testimony.The notes section of the instructions for use ifu0101-0 that accompanies this device instructs the user to inspect the device prior to use for any damage: "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".There is no evidence to suggest that the customer did not follow the instructions for use (ifu0101-0).Document review a review of the qc records did not reveal any issues which could have contributed to this complaint issue.Prior to distribution, all echo-1-22 devices are subjected to functional checks and visual inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl as per qsi0975 all products and packaging are 100% inspected for visual irregularities such as holes, dents, kinks or tears.A review of the manufacturing records for echo-1-22 device of lot# c1413422 did not reveal any discrepancies that could have contributed to this complaint issue.There is no evidence to suggest that this issue affects the entire lot # c1413422 ; upon review of complaints this failure mode has not occurred previously with this lot # c1413422.Summary the customer complaint is confirmed based on the customer testimony.The risk was determined to be no risk (category iii).According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
(b)(4) are all related, unused lots of echo-1-22 are being returned.Two events occurred however it is unknown with which lot, therefore each complaint will be assessed as the event description until clarification is received on which lot the malfunction occurred on.Fda mdr guidance states all suspected lots are to be reported individually.In the patient notes it indicates that they are unsure if the needle was fully retracted prior to patient removal, therefore a conservative approach is going to be taken until further clarification is received.As reported to customer relations: "needles and sticking during ultrasound procedures, when trying to actuate the needle through the endoscope and out of the catheter.Procedures completed by using another device (may have been cook, different gpn, may have been competitor device)." additional information provided on 24may2018: "i was not in the cases and customer reported to me information i in turn reported to you.Customer does not have further detail.I wish i could be of more help.".
Additional Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining (b)(4).Importer site establishment registration number: (b)(4).(b)(4) are all related, unused lots of echo-1-22 are also being returned.Two events occurred however it is unknown with which lot, therefore each complaint will be assessed as the event description until clarification is received on which lot the malfunction occurred on.Each lot is "suspected" and fda mdr guidance states each suspected lot shall be reported individually.Additional information received indicates that they are unsure if the needle was fully retracted prior to patient removal, therefore a conservative approach is going to be taken until further clarification is received.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

• Brand Name: ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
• Common Device Name: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7600882
• Report Number: 3001845648-2018-00277
• Device Sequence Number: 11118378
• Product Code: FCG
• UDI-Device Identifier: 00827002315181
• UDI-Public: (01)00827002315181(17)201020(10)C1413422
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K083330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 10/20/2020
• Device Model Number: G31518
• Device Catalogue Number: ECHO-1-22
• Device Lot Number: C1413422
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/18/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 05/21/2018; 05/21/2018
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 07/12/2018; 08/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1